Posted in Regulatory and Compliance by mthibault on April 5, 2016
A new planning board report details the role of a coordinating center to facilitate the much-anticipated national medical device evaluation system.
A national medical device evaluation system (NMDES) is inching closer to reality. This week, a planning board report from the Duke-Margolis Center for Health Policy set out expectations for a coordinating center that will be tasked with creating the NMDES.
The publication follows two reports last year from the planning board, the Medical Device Registry Task Force, and the Medical Devices Epidemiology Network on the evaluation system. Creation of the NMDES is part of CDRH’s Strategic Priorities for 2016-2017.
This week’s report focuses on the selection of a coordinating center that would develop the NMDES. It would work with all stakeholders, including FDA, CMS, health insurers, patients, manufacturers, and device registries to enable the system. The planning board wrote, “The Coordinating Center will build mutually beneficial shared resources and reusable pathways with standardized data use agreements (DUAs) to drive down the time and cost of generating evidence on medical devices.” Below is a figure from the report depicting its central role:
According to a timeline set out in the report, a coordinating center and an interim executive director are anticipated to be chosen within six months. A governing board and expert committees are expected to be appointed within a year and at least two projects started, with rules for data sharing and access implemented. A medical device evaluation clearinghouse should be available to the public after two years. Projects on safety surveillance and device efficacy evidence development are slated to be done by the third year while a second phase of projects should be started in the second year and finished by the fifth year. The report authors expect the coordinating center and its governing board to be “a financially stable, independent entity” that is scalable and sustainable within five years.
Among the coordinating center’s responsibilities are devising a way to evaluate and share device safety and effectiveness data, and making device evaluation data more affordable, more accessible, and of higher quality. The center’s objectives are summarized in the chart below from the report:
The report also reiterated the shortcoming of current attempts to track medical devices, including the lack of incorporation of unique device identifier (UDI) information, inability to rely on electronic health record (EHR) data, and the absence of widespread stakeholder involvement. “The absence of these capabilities significantly affects the public health and biomedical innovation, by creating obstacles for patients and clinicians to receive the meaningful information they need to make informed decisions, perpetuating unnecessarily long delays and gaps in effective and timely safety communications and recall management, hindering the timely development of new and innovative treatment options, and increasing the overall costs and inefficiency of the health care system,” the report authors wrote.
Many groups have been vocal about the need to include UDI information in such a system as well as insurance claims and EHRs. In January, a Senate committee report reiterated the need for a device evaluation system, pointing to the infamous infectious outbreaks associated with contaminated duodenoscopes as fallout from the lack of such a system.
Josh Rising, MD, director of healthcare programs at The Pew Charitable Trusts, said in a statement at the time, “If UDI data were available in claims, FDA could expand its active surveillance system . . . allowing near real-time detection of safety problems . . . Delay could compromise the safety of millions of Americans, as hundreds of patients who were exposed to infections from duodenoscopes know all too well.”